FDA recall D-0271-2024

Product

Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.

Reason for recall

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Distribution

Nationwide in the USA

Key facts

Status

Completed

Initiation date

2024-01-18

Report date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0271-2024